The development of drug products for pediatric use often requires age-appropriate\nformulations which can be more complex and may involve a broader range of excipients\nthan adult dosage forms. Excipients established for adult use are not always appropriate for use\nin children because they can affect children differently than adults. Therefore, a comprehensive\nsafety assessment of the excipients in a pediatric formulation is essential before use,\nreferring to existing safety data from adult human and animals as well as safety data from\npediatric use and juvenile toxicity studies, when available. The overall risk assessment\nneeds to consider the safety risk from the excipients and the extent to which the risk from\nthe disease as such will be ameliorated by the drug formulation. Non-clinical safety studies\nin juvenile animals are used to assess for specific toxicities or sensitivities of excipients\nand for establishing safe exposures in pediatric age groups. As for any active ingredient,\nnon-clinical safety studies in juvenile animals should only be performed for excipients if\nimportant for clinical risk assessment and labelling. Pharmaceutical companies should be\ncritical of excessive demands for juvenile animal testing, particularly of excipients when\ncritically needed for significant therapeutic benefit.
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